ESTRADIOL
- Product NDC
- 45802-573
- 11-digit product format
- 458020573
- Labeler code
- 45802
- Product ID
- 45802-573_f9b29b00-b229-45cc-91b5-e7df87f857d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA216524
- Marketing category
- ANDA
- Marketing start
- 2023-12-07
- Substance
- ESTRADIOL
- Active strength
- 1.25 mg/1.25g
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216524-001 | ESTRADIOL | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-002 | ESTRADIOL | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-003 | ESTRADIOL | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-004 | ESTRADIOL | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | |
| A216524-005 | ESTRADIOL | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216524-001 | AB |
| A216524-002 | AB |
| A216524-003 | AB |
| A216524-004 | AB |
| A216524-005 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-001 | ESTRADIOL | 0.1% (0.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-002 | ESTRADIOL | 0.1% (0.5GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-003 | ESTRADIOL | 0.1% (0.75GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-004 | ESTRADIOL | 0.1% (1GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-005 | ESTRADIOL | 0.1% (1.25GM/PACKET) | GEL / TRANSDERMAL | AB | 2023-11-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216524-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216524-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216524-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216524-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216524-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216524-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216524-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216524-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216524-005 | AB | 1 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESTRADIOL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | 1.25 mg/1.25g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4TI98Z838E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ac905b3-904c-4285-97ed-e787d006c7dd | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-573-30 | ESTRADIOL | 1.25 g in 1 PACKET | GEL | 1.25 | 25 | |
| 45802-573-30 | ESTRADIOL | 30 in 1 CARTON | GEL | 30 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-573-30 | GM - Gram | 45802-573 | 9ea7aab6-1749-4789-9d9d-6a926d473a55 | 1 | 2024-02-14 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | e6bf2abc-71ae-4e79-a37b-164c98ba746a | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Padagis Israel Pharmaceuticals Ltd | 3ac905b3-904c-4285-97ed-e787d006c7dd | 2026-02-28 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 45802-573 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 0e927450-3f02-4d2f-9235-a255357e8d93 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | 6a4e82a4-d980-4c04-9e33-9444a292728a | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | eab9a629-b3d4-4faf-bce4-656fe3b46d38 | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | 216524 ANDA216524 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2619677 | estradiol 0.1 % (0.25MG / 0.25GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | estradiol 0.1 % (0.5MG / 0.5GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | estradiol 0.1 % (0.75MG / 0.75GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | estradiol 0.1 % (1.25MG / 1.25GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | estradiol 0.1 % (1MG / 1GM) Transdermal Gel | PSN | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | 1000 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | 1250 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619677 | 250 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | 500 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | 750 MG estradiol 0.001 MG/MG Topical Gel | SCD | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619677 | estradiol 0.1 % Transdermal Gel, 0.25 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619679 | estradiol 0.1 % Transdermal Gel, 0.5 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619681 | estradiol 0.1 % Transdermal Gel, 0.75 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619683 | estradiol 0.1 % Transdermal Gel, 1 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
| 2619685 | estradiol 0.1 % Transdermal Gel, 1.25 GM | SY | 3ac905b3-904c-4285-97ed-e787d006c7dd | 25 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 45802-573-30 | 45802057330 | 30 PACKET in 1 CARTON (45802-573-30) / 1.25 g in 1 PACKET | 30 packet | 2023-12-07 | No | No | Current |